I’ve interacted with many patients over the years who are interested in stem cells. This interaction is growing much more frequent. I enjoy interacting with them and have learned a lot this way, but I am often faced with dilemmas.

These patients may be facing fatal illnesses or other conditions that are wreaking havoc on their lives. They may have hit what seem to be insurmountable roadblocks to getting better and finding hope. It is entirely understandable that they want to take action and are wiling to take risks that people not in their shoes may not see the same way. Sometimes it is he parents of patients who call me facing similar challenges and decision making points.

Lately, I get patients or their families contacting me every week and sometimes almost every day.

They are looking for different things.

Some want information. Some want affirmation that it is OK to try experimental therapies at for-profit clinics. Others want the opposite. They want me to confirm their gut feeling not to move ahead with a “treatment”. Some just want to talk or email. I wish I had more time to engage.

They are at different places, but a common thread for them is that they see stem cells as at least one possible source of hope in a reality that otherwise seems pretty hopeless. I get that.

Most often they’ve found a stem cell clinic on the Internet. About eight times out of ten I know the clinic they have on their radar screens and it is usually one that I consider predatory.

What do I mean by a “predatory” clinic?

It is one that sells hype for cash.

There’s really no remotely convincing actual evidence that what this kind of clinic sells is safe or effective. Usually the clinic, if it is in the US, does not have FDA approval for what it sells and generally my best assessment of the “treatment” is that it is of the type that would seem to require FDA approval based on what the FDA has said in the past.

So what am I to do when patients ask about such clinics?

I’ve taken different approaches over the years, but generally I try to point out possible risks or concerns without sounding preachy.

I always strongly suggest talking to their own primary care doctor, which is an appropriate context for them to be considering such decisions. I ask if the patients are also considering what I consider to be “real” clinic trials that don’t directly profit from selling hope, but even those of course have risks so I don’t endorse participation in specific clinical trials either. In general, I emphasize that I do not give medical advice.

Then of course it is important to acknowledge that there is risk of doing nothing in some serious medical illnesses or conditions.

Those of us in the stem cell community who have stepped up to the plate to advocate for the stem cell field including very importantly pointing out the differences between legit clinical stem cell research versus predatory clinics are taking such personal risks. One such person is Dr. Leigh Turner of University of Minnesota who has been a leading proponent of evidence-based medicine in the stem cell field.

Perhaps a complementary or even better approach than individuals working to raise awareness in this area would be for the FDA and state medical boards to take the lead with clear, proactive guidance and importantly prompt action on predatory stem cell clinics in specific cases.

That’s not happening lately.

Even as the number of such clinics continues to grow, paradoxically the FDA seems to be taking less and less action in this area.

Even though the FDA has issued draft guidance in the last few months in areas that could prove helpful in clarifying regulation of stem cell clinic practices, otherwise action from the FDA has been noticeably absent the last 1-2 years.

The reason why remains unknown.

It’s like crickets chirping over at CBER at the FDA, the ones who should be enforcing regulations that some predatory clinics might be breaking every day.

The end result of all of this is a growing array of cowboy stem cell clinics and greatly increased patient risk.

In such a reality, what are individual civic-minded researchers with an awareness of the problem supposed to do?

Speak out?

Because of my past outspokenness about favoring evidence-based medicine (what some call “science-based medicine”) and asking questions about clinic practices, at times certain clinics have threatened to sue me or worse.

That’s no picnic and one has to take such threats seriously.

In the end, governmental and scientific organizations need to step up to create an overall safer climate for patients in the for-profit stem cell arena. This may mean that these organizations take on some level of risk and have to muster the fortitude to face threats of litigation, but it is necessary at this time as we approach a crisis point.

13 Comments

I understand what you are saying but I also think every person should have the right to decide what and where they can have any medical treatment. If you had to get approval for every thing you wish to do in life would it actually be worth being alive. Most of us have the ability and do make decisions every day and some of those decisions fail. Maybe starting a business (it fails and end up bankrupt), going for swim ( get caught in a rip and nearly drown) About 5 years ago I decided to have stem cell treatment against my families advice but I did mention to my cardiologist who said it is a risk but did not try and stop me. It improved my heart and kidney function and since then I have gone back and had another treatment 12 months ago. My be I am one of the lucky ones but I now want to have direct injections into the heart. I am a firm believer in stem cell treatment and do believe it will solve a lot of medical ailments and problems in the future. Yes there may be snake oil clinics just out for money but if people want to take the risks then that should be their own personal option.

I would argue that it is medical doctors that have the responsibility to create a safe climate for patients in general, including in the for-profit stem cell arena.

Scientists are not well placed to do this. A scientist is not regulated like a medical doctor is. A scientist is a free agent and that is the way it should be, IMHO. A scientists job is to publish exactly what he thinks — so that anyone, patients included, can make of it what they may.

In most countries, doctors and engineers have to be members of professional bodies that have legal standing to hold their members accountable — and a duty to do so.

I would have expected scientific organizations to already be working collegially with the professional medical bodies.

I also face similar dilemma… with so much hype being generated by ‘ for Profit Clinics’ thru slick ads & brochures, patients invariably get taken in… there is always a Medical Doctor with impressive degrees & credentials leading such clinics…I find it difficult to dissuade the patient who has already made up his /her mind before contacting me….. I , try to give a true picture to the patients but find my advice was just waste of time & effort !

Freedom to say what you think is at the crux of the matter. As you say:
“Because of my past outspokenness … and asking questions about clinic practices, at times certain clinics have threatened to sue me or worse.”

Freedom of speech is not limited with respect to scientific matters and is only slightly limited with respect to political matters. But freedom of speech is very much limited when it comes to commercial matters. (Commercial law is about making money, not making sense.)

Are we free to critique the scientific basis of a therapy? I think we are.

This is the sort of information that patients need in order to make their own, informed decisions. It is there for all to see — once you look beneath the smothering of glossy advertising.

I call this misleading. But who is causing the deception? It is impossible to say. The company, the sales people and the doctors can all say that they were acting in good faith by claiming that they themselves were fooled.

But they are all on an ethical hook because they did not try hard enough to determine the truth. A passage by “The Ethics of Belief” (1877) by William Clifford comes to mind:

“A shipowner was about to send to sea an emigrant-ship. He knew that she was old, and not overwell built at the first; that she had seen many seas and climes, and often had needed repairs. Doubts had been suggested to him that possibly she was not seaworthy. These doubts preyed upon his mind, and made him unhappy; he thought that perhaps he ought to have her thoroughly overhauled and refitted, even though this should put him at great expense. Before the ship sailed, however, he succeeded in overcoming these melancholy reflections. He said to himself that she had gone safely through so many voyages and weathered so many storms that it was idle to suppose she would not come safely home from this trip also. He would put his trust in Providence, which could hardly fail to protect all these unhappy families that were leaving their fatherland to seek for better times elsewhere. He would dismiss from his mind all ungenerous suspicions about the honesty of builders and contractors. In such ways he acquired a sincere and comfortable conviction that his vessel was thoroughly safe and seaworthy; he watched her departure with a light heart, and benevolent wishes for the success of the exiles in their strange new home that was to be; and he got his insurance-money when she went down in mid-ocean and told no tales.”

I work in a leading research center for regenerative medicine and we were asked to host a visit by a stem cell clinic called GEOSTAR. I am a little worried that this will lead to promotion of the company by association with our university, but on the other hand, this is also what other companies selling devices and research products do. Am being overly sensitive – how can I distinguish between reputable clinics and those putting patients at risk?

@BrianSanderson
thank you for interesting statement.
What do you think about PRP therapy, it seems to work well to repair cartilage and bones. But is it a real stem cell therapy or just similar medical application ?
PRP means to centrifuge the patients blood and to dispense it in a joint.

I wouldn’t trust any stem cell clinic as far as I could throw anyone or anything in it.

That having been said…

My incurable disease was at its worst almost four years ago. Let’s say that at the most hopeless moment, somebody had told me that they knew of a stem cell clinic that had a cure. The only problem was, it was located in the middle of the South Pacific on an uncharted island and could only be reached in a canoe. Once I got there, the clinic would be, oh, a thousand miles from any other inhabited land. A massage therapist would be giving the treatments. Or maybe a giant sea turtle. Hard to say. But look– here’s a nice shiny brochure! Look at all the people who say it helped them!!

I LIKE to think that I wouldn’t have grabbed the oars and started rowing. (Particularly problematic, considering that I lived seventy miles from the ocean.) But I cannot say without a doubt that I would have stayed rational and reasonable. If they caught me at the worst possible moment, I might have started packing lifejackets.

The end of the story, though, is that a regular, marketed drug helped me when NOBODY thought it would. It was a miracle. But if the miracle hadn’t happened, I’m not sure what I might have done. I know what can happen in total desperation, when you just feel like you can’t take one more step, breathe one more breath, make it through one more moment, when you’d do anything to escape the nightmare of an incurable disease. People do crazy things at a time like that, and it doesn’t make sense to blame them for it. Instead, we need to push and work and fight for legitimate stem cell based treatments to help everyone.

Paul, I know you have written in the past that just because a clinical trial is listed on clinicaltrials.gov, it is not necessarily approved by the FDA – but at least it does give one some confidence that it is legit — again, except for the ones that are not, like some we have discussed and which I don’t list in my tables of stem cells in ophthalmology clinical trials.

Anyone interested can find an up-to-date listing of current and completed clinical trials using stem cells in ophthalmology by visiting the table I have posted online at: http://tinyurl.com/StemCellClncl423